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PRODUCT DETAIL

Daptomycin Reddy 500 mg prášok na injekčný/infúzny roztok

Code 7505E
MA number 15/0236/24-S
Product Form: plo ijf 5x500 mg (liek.inj.skl.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Reddy Holding GmbH, Germany
Therapeutic Class: 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM)
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J01X OTHER ANTIBACTERIALS
J01XX Other antibacterials
J01XX09 Daptomycin
Shelf life: 24
Container: colourless glass vial (type 1), rubber stopper (type 1)
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 03.10.2024
Validity: 03.10.2029
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Daptomycin Reddy 350mg; 500 mg_09_2024.pdf  
SPC: SPC_Daptomycin Reddy 350mg; 500mg_09_2024.pdf  
Safety feature Yes
Data update: 04.10.2024
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